MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number LP4.5-SLF40

Device Problems Corroded (1131); Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is pending.The root cause is unable to be determined at this time.A supplemental report will be provided when the evaluation has been completed.

Event Description

Information was received that upon removal, the plate was noted to have discoloration and corrosion.

Manufacturer Narrative

Device evaluation: visual inspection of the returned plate revealed that the distraction rod of the plate had discoloration which confirmed the failure mode.Per the reported failure functional testing was not applicable.The reported failure mode is being investigated for root cause.Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.

Event Description

No additional information was provided.

• Brand Name: PRECICE PLATING SYSTEM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11888504
• MDR Text Key: 256796443
• Report Number: 3006179046-2021-00287
• Device Sequence Number: 1
• Product Code: HTT
• UDI-Device Identifier: 00887517021267
• UDI-Public: 887517021267
• Combination Product (y/n): N
• PMA/PMN Number: K192181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LP4.5-SLF40
• Device Lot Number: 0071412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR